UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043986 |
|---|---|
| Receipt number | R000050235 |
| Scientific Title | Walking through an aperture while leading paretic side training for patients with unilateral spatial neglect |
| Date of disclosure of the study information | 2021/04/21 |
| Last modified on | 2025/02/03 09:13:53 |
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Basic information
Public title
Walking through an aperture while leading paretic side training for patients with unilateral spatial neglect
Acronym
Walking through an aperture training for patients with unilateral spatial neglect
Scientific Title
Walking through an aperture while leading paretic side training for patients with unilateral spatial neglect
Scientific Title:Acronym
Walking through an aperture training for patients with unilateral spatial neglect
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether obstacle avoidance training that passing through a narrow aperture from the paretic side contributes to the improvement of contact rate, walking ability, and balance ability for the stroke patients with unilateral spatial neglect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The mean percentage of contacts with the frame of an aperture (The timing of the measurement is before and after the intervention)
Key secondary outcomes
The following assessment excluding the falls incident is carried out before and after the intervention.
10m walking test (10MWT)
Timed up and Go Test (TUG)
Berg Blance Scale (BBS)
Catherine Bergego Scale (CBS)
Walking speed and trunk rotation angle at the time of passage
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
In the intervention periods for three weeks, participants through a narrow aperture (0.9, 1.0.1.1, 1.2 times of their shoulder width) in the walking path of 5 m, five times a week for 40 minutes. If they decide that it is necessary to rotate, they penetrate an aperture from the paretic side.
In the control or follow up periods for three weeks, participants received regular physical therapy intervention.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants were patients with unilateral spatial neglect in a subacute hospital and they had residual hemiparesis.
The inclusion criteria ensured that participants had been walking for at least one month after a first-time stroke and that they were able to walk independently for more than 100 m with or without an assistive device.
Key exclusion criteria
The exclusion criteria ensured that none of the participants had any indications of the following symptoms: (a) neurological, orthopedic, or other disorders that could affect walking, and (b) a score of less than 24 on the Mini Mental State Examination (MMSE)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Muroi |
Organization
Kameda University of Health Science
Division name
Research Institute
Zip code
296-0001
Address
462 Yokosuka, Kamogawa, Chiba 296-0001, Japan
TEL
0470991211
mutyon88@hotmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Muroi |
Organization
Kameda University of Health Science
Division name
Research Institute
Zip code
296-0001
Address
462 Yokosuka, Kamogawa, Chiba 296-0001, Japan
TEL
0470991211
Homepage URL
mutyon88@gmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center
Address
929 Higashicho, Kamogawa, Chiba 296-8602, Japan
Tel
0470922211
clinical_research@kameda.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.tandfonline.com/doi/full/10.1080/13554794.2022.2042566
Publication of results
Partially published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/13554794.2022.2042566
Number of participants that the trial has enrolled
1
Results
The intervention improved the continuous
walking distance and balance ability and decreased the number of collisions when walking through the narrow opening; however, it exerted a minimal effect on ADL.
Results date posted
| 2022 | Year | 10 | Month | 22 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to a lack of cases.
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 10 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
Accepted by an international journal (Neurocase).
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 20 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050235
